Medical line anchoring system

ABSTRACT

An anchoring system includes a simply-structured device which permits a portion of a catheter tube or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suturing. A unitary retainer desirably includes a base connected to a cover by way of a flexible hinge. The retainer is attached to a flexible anchor pad including an adhesive bottom surface, which can be attached to the patient&#39;s skin. A catheter is secured to a fitting, which in turn mounts to the retainer. Mounting the fitting to the retainer can be accomplished by inserting posts of the retainer through holes of the fitting, or by mounting the fitting within a channel defined by mounting structures integral to the retainer. The cover is then positioned over the base, by bending the flexible hinge, and latched to the base. Several embodiments of the latching mechanism are disclosed. In one form, the latching mechanism includes one or more posts on the base which can be releasably locked into corresponding slotted holes in the cover.

RELATED CASES

The present application is a continuation of application Ser. No.09/797,341 filed on 1 Mar. 2001 now U.S. Pat. No. 6,447,485, which is adivisional of application Ser. No. 08/865,231, filed on 29 May 1997 nowU.S. Pat. No. 6,213,979.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to anchoring systems for anchoring medicallines to patients.

2. Description of Related Art

It is very common in the treatment of patients to utilize intravenous(IV) catheters to introduce fluids and medications directly into thebloodstream. In many cases, and particularly with respect to cardiactherapy, the IV catheter is introduced into a central or larger veinlocated close to the patient's heart. A typical catheter utilized inconnection with a central vein is referred to as a “central venouscatheter” (“CVC”). A venous catheter peripherally inserted into thecentral circulation through a vein in the arm is commonly referred to asa “peripherally inserted central catheter” (“PICC”).

In these cases, long-term IV infusion typically requires that thecatheter remain in place for many days. In order to secure such an IVcatheter in position at the insertion site, the catheter often isprovided with an integrated or a movable flexible clamp with wingedextensions which are sutured to the patient's skin. In otherapplications, the flexible clamp is covered by a rigid box clamp, whichreceives the catheter/clamp combination in a friction-fit manner. Therigid box clamp and the flexible clamp have lateral, aligned holes inthem, which allow the combination to be sutured to the patient's skin.Although this technique securely attaches the central venous catheter tothe patient, it obviously is painful and uncomfortable for the patient.This prior retention procedure is also time consuming and inconvenient,poses the risk of needle-stick to the health care provider, and riskssuture-site infection to the patient. In addition, suture material tendsto exhibit poor gripping on medical tubes and can cut through the wingedextension of the flexible clamp.

SUMMARY OF THE INVENTION

A need therefore exists for a simply-structured anchoring system thataffixes a medical line in a fixed position, but releases the medicalline for dressing changes or other servicing.

On aspect of the present invention thus involves an anchoring system forsecuring a medical line to the body of a patient. The system comprises aretainer including a base that defines a receiving area for receiving aportion of the medical line. A cover is permanently coupled to the base.The cover is movable between a closed position, in which at least aportion of the cover extends over at least a portion of the receivingarea, and an open position, in which the receiving area is at leastpartially open. A latching mechanism operates between the base and thecover to releasably latch the cover to the base with the cover in theclosed position. Interacting structure is located generally beneath thecover with the cover in the closed position. The interacting structureis adapted to limit movement of the medical line through to the retainerwhen the catheter is placed within the receiving area.

Another aspect of the present invention involves an anchoring system forsecuring a medical line to the body of a patient. The system includes afitting adapted to engage with the medical line and having at least oneopening. A retainer comprises a base including a platform and at leastone post extending from the platform and arranged to interact with thehole of the fitting. A cover is movably coupled to the base so as to bemoved between an open position and a closed position. A latchingmechanism operates between the cover and the base to releasably latchthe cover to the base in the closed position.

In accordance with an additional aspect of the present invention, ananchoring system for securing a medical line to the body of a patient isprovided. The anchoring system comprises an adaptor having an adaptorbody with a longitudinal axis defined between first and second ends. Afirst connector is located at the first end of the adaptor forconnection to a first medical line, and a second connector is located atthe second end for connection to a second medical line. A retainerincludes a base and a cover permanently coupled to the base. The coveris movable between an open position and a closed position. A latchingmechanism releasably latches the cover to the base in the closedposition. And a channel is arranged to lie between the base and thecover in the closed position. The channel is shaped to retain theadaptor between the cover and the base with the cover in the closedposition to inhibit movement of the adapter in a direction generallyparallel to the adapter's longitudinal axis. An adhesive layer isattached to the retainer and is adapted to adhesively secure theretainer to the body of a patient.

A preferred method of anchoring a medical line to a patient involvesproviding a retainer including a base having a plurality of posts, and acover attached to the base by a flexible leash. The provided cover alsoincludes a corresponding plurality of openings with each openingcomprising a slot. The retainer is coupled to an adhesive layer. Theanchoring system is positioned on the body of the patient, and theadhesive layer is attached to the body of the patient. A medical deviceis arranged between the posts of the base. The cover is positioned overthe base to bring the openings of the cover in proximity with the postsof the base. The cover is shifted relative to the base to engage theposts with the slots of the openings.

Further aspects, features, and advantages of the present invention willbecome apparent from the detailed description of the preferredembodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features of the invention will now bedescribed with reference to the drawings of several preferredembodiments of the present anchoring system. The illustrated embodimentsof the anchoring system are intended to illustrate, but not to limit theinvention. The drawings contain the following figures:

FIG. 1A is a perspective view of an anchoring system in accordance witha preferred embodiment of the present invention and illustrates aretainer of the anchoring system in an open position together with anexemplary catheter wing clamp fitting (the components of which areillustrated as exploded above the retainer);

FIG. 1B is a bottom plan view of a cover of the retainer of FIG. 1A;

FIG. 2 is a perspective view of the anchoring system of FIG. 1A with thecover of the retainer shown in a partially closed position;

FIG. 3 is a cross-sectional view of the anchoring system of FIG. 2, withthe retainer shown in a completely closed position and the catheter wingclamp fitting assembled and anchored therein;

FIG. 4A is a perspective view of a retainer in accordance with anotherpreferred embodiment of the present invention, shown in an openposition;

FIG. 4B is a bottom plan view of a cover portion of the retainer of FIG.4A;

FIG. 5 is a perspective view of the retainer of FIG. 4A, shown in apartially closed position;

FIG. 6 is a perspective view of a retainer in accordance with anotherpreferred embodiment of the present invention, shown in an openposition;

FIG. 7 is a perspective view of the retainer of FIG. 6, shown in aclosed position;

FIG. 8 is a cross-sectional view of the retainer of FIG. 7, taken alongthe line 8—8;

FIG. 9 is a cross-sectional view of the retainer according to FIG. 8,but with a tang shown in a release position;

FIG. 10A is a prospective view of an anchoring system in accordance withan additional preferred embodiment of the present invention andillustrates a retainer of the anchoring system in an open position andtogether with an exemplary catheter adaptor;

FIG. 10B is a bottom plan view of a cover portion of the retainer ofFIG. 10A;

FIG. 11 is a prospective view of the retainer of FIG. 10A, shown in apartially closed position with the cover interacting with the catheteradapter; and

FIG. 12 is a cross-sectional view of the retainer according to FIG. 11,shown in a completely closed position, with the catheter adaptoranchored therein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present embodiments of the medical line anchoring system aredisclosed in the context of an exemplary central line catheter. Theprinciples of the present invention, however, are not limited to PICCsor CVCs. Instead, it will be understood by one of skill in this art, inlight of the present disclosure, that the anchoring systems andretainers disclosed herein also can be successfully utilized inconnection with other types of medical lines, including tubes for fluidcommunication and electrical wires. For example, but without limitation,the retainers disclosed herein can retain CVCs, PICCs, Foley catheters,and hemodialysis catheters, surgical drainage tubes, feeding tubes,chest tubes, nasogastric tubes, scopes, as well as with electrical wiresor cables connected to external or implanted electronic devices orsensors. One skilled in the art may also find additional applicationsfor the devices and systems disclosed herein. Thus, the illustration anddescription of the anchoring system 8 in connection with a catheter ismainly exemplary of one possible application of the system.

Each of the embodiments described herein employ the same basic conceptscharacteristic of the improved anchoring system, namely releasableattachment of a medical line to a patient. The anchoring systems alsoall include interacting structure that operates between a retainer ofthe anchoring system and a fitting which in some applications isreleasably attached to the medical line and in other applications isintegrally formed with the medical line. The interacting structurebetween the retainer and the fitting generally inhibits relativemovement between the medical line and the anchoring system in at leastone degree of freedom.

To assist in the description of the components of the anchoring systemsand retainers disclosed herein, the following coordinate terms are used.A longitudinal axis is generally parallel to a section of the medicalline to be retained by the anchoring system, generally in the plane of aretainer base (discussed below). A lateral axis is generallyperpendicular to the longitudinal axis within the plane of the base. Atransverse axis extends transverse to both the longitudinal and lateralaxes. A number of the figures illustrate this coordinate system to theside of the anchoring system. In addition, as used herein, the“longitudinal direction” refers to a direction substantially parallel tothe longitudinal axis. “The lateral direction” refers to a directionsubstantially parallel to the lateral axis. And, “the transversedirection” refer to a direction substantially parallel to the transverseaxis. These coordinates are used to describe structures and movement ofthe anchoring system of each embodiment. A detailed description of eachembodiment, and its associated method of use, now follows.

FIGS. 1 to 3 illustrate an anchoring system 8 constructed in accordancewith a preferred embodiment of the present invention. The system 8includes a retainer 10 which is configured to retain a catheter, eitherdirectly or by way of a fitting 11. In the illustrated embodiment, thefitting 11 comprises a catheter box clamp 12 and a soft wing clamp 13for use with a central line catheter 15.

The retainer 10 includes a base 14. The base 14 of the retainer 10 isattached to an anchor pad 16, which forms a part of the anchoring system8. The base 14 desirably is secured to the anchor pad 16 by a solventbond adhesive, such as cyanoacrylate or other bonding material. One suchadhesive is available commercially as Part No. 4693 from the MinnesotaMining and Manufacturing Company (3M).

The anchor pad 16 comprises a flexible structural layer for securing theretainer 10 to a patient's skin. The pad desirably comprises a laminatestructure with an upper cellulose foam layer (e.g., closed-cellpolyethylene foam), and a bottom adhesive layer. The adhesive desirablyis a medical-grade adhesive and can be either diaphoretic ornondiaphoretic, depending upon the particular application. Such foamwith an adhesive layer is available commercially from New Dimensions inMedicine of Columbus, Ohio. Although not illustrated, it will beunderstood that the retainer and/or anchor pad can include suture holesin addition to the adhesive layer to further secure the anchor pad tothe patient's skin.

An upper surface of the foam layer is roughened by corona-treating thefoam with a low electric charge. The roughened or porous upper surfaceof the anchor pad 16 improves the quality of the adhesive joint formedby the cyanoacrylate (or by another type of adhesive or bondingmaterial) between the base 14 to the anchor pad 16. In the alternative,the flexible anchor pad 16 can comprise a medical-grade adhesive bottomlayer, an inner cellulose foam layer and an upper paper or other wovenor non-woven cloth layer.

A removable paper or plastic backing 17 desirably covers the bottomadhesive surface before use. The backing 17 preferably resists tearingand is divided into a plurality of pieces to ease attachment of the padto a patient's skin. Desirably, the backing 17 is split along a centerline 18 of the flexible anchor pad 16 in order to expose only half ofthe adhesive bottom surface at one time. The backing 17 alsoadvantageously extends beyond at least one edge of the anchor pad 16, asillustrated, to facilitate removal of the backing 17 from the adhesivelayer.

In the illustrated embodiment, the anchor pad 16 also desirably includesa pair of opposing concave sections that narrows the center of theanchor pad proximate to the base 14. As a result, the peripheral ends ofthe anchor pad 16 have more contact area to provide greater stabilityand adhesion to a patient's skin, while allowing the retainer 10, whichis located at center section of the anchor pad 16, to be placed adjacentto an insertion site of the catheter 15.

Although the anchor pad 16 has not been shown in the other drawings thatillustrates this embodiment, nor in some of the drawings illustratingthe other embodiments, it will be understood that a similar flexibleanchor pad is included to secure the retainer to the patent's skin witheach embodiment.

The base 14 and the catheter 15 desirably include interacting structureto couple the catheter 15 to the base 14. As will be clear from thedisclosure below, the interacting structure mounts the medical lineeither directly or by way of a fitting (e.g., the box clamp 12 and softwing clamp 13) to the base 14. In the latter case, a portion of theinteracting structure desirable is formed on the fitting and anotherportion of the interacting structure is formed on the retainer. The term“mount,” when used with reference to the relation between the catheteror fitting and the retainer, does not necessarily imply that thecatheter 15 or fitting 11 are immobilized or fixed. Rather, this term ismeant to describe the condition in which the interacting structureinhibits movement of the catheter 15 relative to the retainer 10 in atleast one degree of freedom (e.g., rotational, lateral, longitudinal ortransverse). In the illustrated embodiment, as well as in those laterdescribed, the interacting structure inhibits movement of the catheter15 at least in the longitudinal direction.

In the illustrated embodiment, a portion of the interacting structure onthe base 14 comprises at least one post 20 which extends upwardly from arelatively rigid platform 21. The base 14 desirably includes a pair ofposts 20. The base can also include additional posts to suit a specificapplication. For example, where the retainer is designed to secure arelatively large fitting, the base can include four posts arranged atthe comers of a rectangle, for greater stability. And, three posts canbe used to firmly anchor a Y-site fitting.

Each post 20 includes a shank or shaft 25, attached to and extendingupwardly from the platform 21. The posts 20 can have a variety oflengths and a variety of distances between them, depending upon theparticular application and the particular fitting 11 with which they areto interact to mount the catheter 11. For anchoring catheters andmedical tubing, each post 20 desirably has a length of about 4 mm to 20mm, and more particularly a length of about 6 mm; however, longer orshorter lengths also are possible. The posts 20 are laterally spaced atleast wide enough to accommodate the medical line to be anchored, and inthe illustrated embodiments, the posts 20 are spaced to accommodate thefitting 11 which secures the medical line. Desirably, the posts 20 arespaced apart by a distance between 5 mm and 40 mm, and more particularlyby a distance equal to about 15 mm. The shaft 25 of each post 20 has adiameter sufficient to perform its structural function, as described inmore detail below, and depends upon the material chosen for the base 14and shafts 25. The illustrated posts 20 comprise a polymer plasticmaterial, with a diameter between 0.5 mm and 3 mm and particularly about1.7 mm.

At least one protrusion extends radially from the shaft. In theillustrated embodiment, the protrusion comprises an enlarged tip or head26 at the end distal from the platform 21. As seen in FIG. 1, at least aportion of the head 26 of each post 20 is larger than the diameter ofthe shaft 25, desirably having a maximum diameter of 1.1 to 1.5 timesthe diameter of the shaft 25. In the illustrated embodiment, the head 26has a generally hemispherical shape with a smooth surface and a maximumdiameter at an overhanging lower surface or underside 30. It will beunderstood, however, that the head 26 can take a variety of othershapes, such as for example, solid or hollow conicals, arrowheads,barbs, spheres, mushroom heads, and other types of radially projectingstructures. A relatively blunt end of the head 26 is preferred to avoidsnagging on materials such as a health care provider's latex gloves orsheets on the patient's bed.

A cover 22 is flexibly coupled to the base 14 by way of a flexiblecoupling. In the illustrated embodiment, the coupling comprises aflexible leash 24. The leash 24 can take any number of forms tomechanically connect the base 14 to the cover 22 while permittingmovement of the cover 22 relative to the base 14 so as to enableengagement or disengagement of these parts, as described below. In theillustrated embodiment, the leash 24 comprises a band of flexiblematerial. The leash 24 desirably is integrally molded with the base 14and the cover 22. The illustrated leash 24 has a longitudinal width ofabout 0.5 mm to 5 mm, desirably about 1 mm, and a similar depth ortransverse dimension. The length of the leash 24 depends in part uponthe height of the post 20. Desirably, the leash 24 is longer than theheight of the post 20, to allow some leeway in engaging or disengagingthe base 14 with the cover 22, as will be understood by one of skill inthe art in light of the disclosure herein. While the leash 24 desirablyis generally oblong in cross-section, as illustrated, and fixes anorientation of the cover 22 relative to the base 14, it will beunderstood that the leash can also have a string-like (e.g., rounded)configuration and allow rotation about the lateral axis.

The cover 22 comprises an elongate member which can be formed of thesame polymer or plastic material as the base 14, and desirably isintegrally molded with the base 14. The cover 22 desirably has a shapethat is generally coextensive with the platform 21 of the base 14. Thecover 22 can be smaller; however, the cover should have a length in thelateral direction at least large enough to extend over the space betweenthe posts 20 and a width in the longitudinal direction that is widerthan the posts 20. The width of the cover 22 desirably is sufficient tostabilize a section of the catheter 15 within the retainer 10. Inparticular, the width of the cover 22 preferably generally matches thelongitudinal length of the fitting 11. The comers of the cover are alsodesirably rounded to avoid snagging on materials such as the latexgloves worn by the health care provider, bed sheets, etc. In theillustrated embodiment, the cover 22 generally has an elliptical shapefor this purpose.

As shown in FIG. 2, the illustrated cover 22 also desirably includes atextured portion 48, such as that formed by longitudinal ridges 50 inthe cover surface at an end of cover 22 opposite of the leach 24. Itwill be understood that any well known form of texturing such as, forexample, a roughened surface can be used in place of ridges. Thetextured portion 48 improves the health care provider's grip on thecover 22.

The base 14 and cover 22 are further releasably connected by a latchingmechanism. The latching mechanism permits the cover 22 to be engage withthe base 14 in a closed position, as illustrated in FIG. 3. The cover 22also can be disengaged from the base 14 and moved to an open position,as shown in FIG. 1A.

The latching mechanism includes interengaging structures formed on thebase 14 and on the cover 22. In the illustrated embodiment, the portionof the latching mechanism on the base 14 is formed by at least one ofthe posts 20 with it enlarged head 26. Desirably, the latching mechanisminvolves the posts 20 that lie on opposite sides of the catheter 15 whenthe catheter 15 is properly positioned on the retainer 10.

A cover portion of the latching mechanism includes at least one opening32 formed in the cover 22, and desirably includes the same number ofopenings 32 as there are posts 20 on the base 14. The illustrated cover22 thus includes two openings 32 with corresponding points of theopenings 32 being spaced by approximately the same distance as the twoposts 20 on the base 14, desirably by between about 5 mm and 40 mm, andparticularly about 15 mm. Each opening 32 is arranged in the cover 22 tocooperate with the corresponding post 20. It will be understood that, inother arrangements of the latching mechanism are possible where theposts are on the cover, the openings are formed in the base, asdescribed in more detail below.

Each opening 32 shown in FIGS. 1-3 is defined by a central hole 34 withat least one slot 36 extending to one side, desirably laterally adjacentto and intersecting with the central hole 34 at a narrow waist opening37. The central hole 34 is sized and shaped to accommodate the largestdiameter of the post head 26. The illustrated slot 36 extends in thelateral direction from the central hole 34 with the lateral axis of theslot 36 being substantially collinear with a center line of the cover 22extending in the lateral direction. It will be understood that the slots36 on the cover 22 can extend from the central hole 34 in any direction,though both slots 36 desirably extend in the same general direction. Inother arrangements, more than one slot can extend from each centralhole.

The width of the illustrated slot 36 in the longitudinal direction issmaller than the central hole 34 and is smaller than the largestdiameter of the head 26. The slot width desirably ranges from slightlysmaller to slightly larger than the diameter of the shaft 25.

The interengagement between the posts 20 and the openings 32 on thecover 22 thus form the latching mechanism that releasably secures thecover 22 to the base 14. When the post shaft 25 is positioned in theslot 36, the cover 22 can not be lifted from the retainer base 14 in thetransverse direction, as described in more detail below.

As best seen from the plan view of FIG. 1B, the cover 22 desirablyincludes a post retention mechanism to inhibit unintentional retractionof a post 20 from the slot 36. In the embodiment of FIGS. 2-3, theretention mechanism includes a lip 38 of cover material that forms adepression 40 (FIG. 3). The depression 40 is sized slightly smaller thanthe lower surface 30 of the post head 26. The retention mechanism of theillustrated slotted hole 36 further comprises the waist opening 37 (FIG.18), which has a slightly smaller diameter than the shaft 25. Thelongitudinal dimension of the slot 36 widens to slightly larger than thediameter of the shaft 25 between the lip 38 of the cover 22. While notillustrated, the retention mechanism can also be formed by arranging theslots at a slight deviation from parallel to one another to increase thefriction between the cover 22 and the posts 20.

The retainer 10 also desirably includes a locator device to locate thecover 22 at a desired distance from the platform 21. In the illustratedembodiment, each post 20 includes an annular ring 28 positioned betweenthe platform 21 and the head 26 for this purpose; however, other typesof protuberances (e.g., small bumps or ribs) can also serve thispurpose. The annular ring 28 is spaced below the head 26 along the shaft25 by a distance sufficient to accommodate the thickness of the cover 22when latched together. The ring 28 desirably is located between about 1mm and 4 mm below the lower surface 30 of the head 26. Like the head 26,the annual ring 28 is larger in diameter than the shaft 25, desirably1.1 to 2.0 times the diameter of the shaft 25. Most desirably, the ring28 is slightly larger than the maximum diameter of the head 26.

As mentioned above, the base 22, leash 24 and cover 22 desirably areintegrally formed to make a unitary retainer 10. This can beaccomplished in any of a variety of ways well known to one of skill inthe art. For instance, the entire retainer can be injection molded, inorder to reduce fabrication costs. Additionally, features such as theleash 24 are desirably flexible. Suitable plastics which account forthese considerations include polypropylene, polyethylene, and the like.Desirably, the illustrated retainer 10 comprises injection moldedpolyethylene or polypropylene.

The anchoring system 8 can also include the fitting 11 for mounting amedical line (e.g., catheter) to the retainer 10. In the exemplaryapplication illustrated in FIGS. 1-3, the fitting 11 takes the form ofthe box clamp 12 and the soft wing clamp 13. Mounting of the fitting 11(or catheter directly) to the retainer 10 is achieved by way of theinteracting structures, a portion of which comprises surfaces orstructures of the retainer 10 and another portion of which comprisessurfaces or structures of the fitting 11 (or catheter, if directlycoupled).

The box clamp 12, best seen from the view of FIG. 1, is a relativelysmall, rigid wing-shaped device having a configuration similar to thatof conventional box clamps in common usage today in suturing attachmentsystems. The box clamp 12 includes a central elongate body 60 having alongitudinal groove 62 formed on the underside and a box-shaped uppersurface 64. The longitudinal groove 62 is generally U-shaped and issized to receive the body of a catheter and/or associated fluid line,and more desirably is sized to receive the wing clamp 13. At least oneend, and preferably at both ends of the longitudinal groove 62, the body60 of the box clamp 12 narrows the opening of the longitudinal groove62. That is, the longitudinal groove 62 at either end extends through anarc which is greater than 180E about an axis of the longitudinal groove62. The groove also can have a uniform cross section along its length sothat the wall of the entire groove extends through an arc greater than180E. The box clamp 12 desirably is formed of a relatively rigidmaterial, such as polycarbonate.

A pair of lateral wings 66 extend roughly perpendicularly from the body60 of the box clamp 12, each including a hole 67 therethrough. Each hole67 is sized and shaped to receive the head 26 and the collar 28 of oneof the posts 20.

The soft wing clamp 13 has a configuration similar to that of the boxclamp 14, including a central elongate body 70 defining an inner cavity72 and an outer surface 74. The inner cavity 72 is sized to surround aportion of a catheter. The wing clamp 13 is constructed from a soft,pliable or flexible material such as, for example, latex or the like.The central elongate body 70 includes a longitudinal slit 75 along itsunderside. The slit 75 can be expanded due to the pliable nature of thewing clamp 13. Thus, the wing clamp 13 is capable of being placed on andsurrounding and longitudinally contacting in a frictional manner aportion of the catheter. This frictional contact between the soft wingclaim 13 and the catheter generally prevents relative movement betweenthese articles.

Lateral wings 76 extend roughly perpendicularly from the body 70 of thesoft wing clamp 13, each including a through-hole 77. Each hole 77 issized and shaped to receive the head 26 of one of the posts 20. As thematerial surrounding the wing hole 67 is pliable in the illustratedembodiment, the hole 67 can be smaller than the corresponding box clamphole 67 and even smaller than the post head 26, yet still be stretchedto receive the post head 26; the through-hole 77, however, desirably islarger than the post head 26 and generally equal in size to thecorresponding hole 67 in the box clamp 12.

The illustrated box clamp 12 and soft wing clamp 13 are commerciallyavailable from Arrow® for use with its CVC. Other clamps with suturewing extensions are currently in commercial use with Quinton®Hemodialysis catheters, Cook® PICC's, Baxter® CVCs and B. Braun CVCs.The skilled artisan will find application for the present invention withany of these and many other clamp configurations. As will be clear froma discussion of the embodiment of FIGS. 10-12, the fitting 11 (boxclamp/soft wing clamp combination) can also be replaced with aninter-line connector or adaptor, such as those used to connect thecatheter to a supply, delivery or drainage line.

FIG. 3 illustrates the interengagement of the components of theanchoring system 8, in accordance with the present embodiment. The boxclamp 12 and soft wing claim 13 are shown engaged with the posts 20 andretained between the base 14 and cover 22 of the retainer 10.

As noted, the groove 62 of the box clamp 12 is configured to receive thesoft wing clamp 13. In particular, the groove 62 is sized and shaped toreceive the outer surface 74 of the elongate body 74 on the soft wingclamp 13. The wings 66 of the box clamp 12 have approximately the samesize and shape as the wings 76 of the soft wing clamp 13. When the wings66, 76 are aligned, the box clamp holes 67 are correspondingly alignedwith the soft wing clamp holes 77.

Together, the box clamp 12 and the soft wing clamp 13 form the fitting11 for mounting in the retainer 10. In the illustrated embodiment, theretainer 10 has been sized for retention of the conventional box clamp12 and soft wing clamp 13. Accordingly, the holes 67, 77 of the fitting11 are spaced by approximately the same distance as the posts 20 on theretainer base 14. The box-like upper surface 64 of the box clamp 12 issized and shaped to fit between the posts 20. Accordingly, a lateraldimension of the elongate body 60 is smaller than the spacing betweenthe posts 20 (i.e., the elongate body 60 is located between and spacedfrom holes 67 on the box clamp wings 66), while the height of thefitting 11 (formed by the height of the box clamp 12 plus the thicknessof the soft wing clamp wings 76) is smaller than the height of theposts. Desirably, the height of the fitting is smaller than the heightof the shaft 25 up to the underside 30 of the post head.

The interaction between the posts 20 and the openings 67, 77 of thefitting 11 mount the fitting 11 on the base 14. Accordingly, thisinteracting structure between the retainer 10 and the fitting 11inhibits movement of the catheter 15 relative to the retainer 11 in atleast the longitudinal and lateral directions. It is understood that theposts need not to extend entire through the holes for this purpose,though.

As noted above, the spacing between the posts 20 on the base 14 alsodictates the spacing between the openings 32 in the cover 22. Desirably,the slots 36 each extend from the same side, and desirably laterally,from the central holes 34. Thus, the spacing between the central holes34 is approximately equal to the spacing between the slots 36, which isin turn approximately equal to the spacing between the posts 20 on thebase.

As also noted above, the leash 24 flexibly connects the platform 21 ofthe base 14 to the cover 22. Desirably, the leash 24 connects lateralends of the base 14 and cover 22, so as not to interfere with themounting of the fitting 11 and catheter along the longitudinal axis. Theleash 24 is long enough to permit a desired parallel spacing of the base14 from the cover 22 when the retainer is in a closed position, asillustrated.

In operation, a catheter (or other medical tube or wire) is insertedinto the patient, and the fitting 11 is secured to the catheter. Thefitting 11 is then retained within the retainer 10, and the retainer 10is then secured to the patient. These steps are described in more detailbelow. While this sequence is advantageous, it will be understood that,in other arrangements, the fitting can be secured to a catheter beforeor after securing the fitting to the retainer, depending upon the formof the fitting. Similarly, and especially for reapplication of acatheter to the retainer 10, the catheter and fitting 11 can be mountedto the retainer 10 after the retainer 10 has already been secured to thepatient.

In the illustrated embodiment, desirably after catheter insertion, thewing clamp 13 is stretched open at the slit 75 and fit over thecatheter, as in standard practice. The groove 62 of the box clamp 12 isfitted over the elongate body 70 of the soft wing clamp 13, providing atight “snap fit.” Some flexibility in the wing clamp body 70 facilitatesthis fitting. The relatively more rigid box clamp body 60, however,exerts relatively more inward pressure on the catheter than therelatively more flexible wing clamp 13, such that a better frictionalgrip holds the catheter within the fitting 11. It will be understood byone of skill in this art, however, that the fitting 11 of the presentembodiment can comprise the soft wing clamp 13 alone.

As shown in FIG. 2, the catheter and fitting 11 are then removablymounted to the retainer 10. In the illustrated embodiment, the holes 77,67 are fitted over the posts 20 of the retainer base 14. Desirably, eachslightly smaller wing clamp hole 77 stretches to accommodate the largerdiameter head 26 and ring 28 of the post 20. Each box clamp hole 67, onthe other hand, desirably is large enough to receive the head 26 andring 28 without interference. The fitting 11 is thereby fitted onto thebase 14 with the posts 20 extending through the fitting holes 67, 77 andthe bottom surface of the soft wing clamp 13 resting on the platform 21.

As illustrated in FIGS. 2 and 3, the cover 22 is latched to the base 14,with the fitting 11 interposed between the cover and the base. FIG. 2shows the cover 22 in a partially closed position, with the flexibleleash 24 bent to position the cover 22 over the base 14. The openings 32of the cover 22 are aligned with the posts 20 of the base 14 and thecover 22 is then moved toward the base such that the head 26 of eachpost passes through the central hole 34 of one of the openings 32. Thesize and spacing of the openings 32 and the posts 22 should result in aneasy engagement so that only a light downward force is necessary,thereby avoiding pain or discomfort to the patient. In this position,the portion of the cover 22 between the holes 34 can firmly contact aportion of the fitting 11 in some applications.

The rings 28 can also support, at least in part, the cover 22, or atleast limit the travel of the cover 22 over the posts 20 so as toproperly position the cover 22 on the posts 22 generally beneath theflared heads 26. Once the heads 26 of the posts 20 have cleared thecentral holes 34 in the cover 22, the cover 22 contacts the ring 28.

The cover 22 is then slid laterally (to the right, in the views of FIGS.2 and 3) so that the shaft 25 of each post 20 slides past the narrowwaist opening 37 into the corresponding slot 36. The cover material atthe waist 37 and/or the shaft 25 slightly compresses as the cover 22 isshifted under force provided by the health care provider. Desirably, theretainer is arranged such that, when the posts 20 are engaged with theslots 36, the cover 22 is centered with respect to the base.

The resulting engagement, shown in FIG. 3, serves to retain the fitting11 securely in place within the retainer 10. As the waist openings 37are desirably slightly more narrow than the post shafts 25, the slots 36provide a friction or snap fit engagement with the posts 20. The slots36 are longitudinally more narrow than the post heads 26, such that thecover 22 cannot be transversely lifted away from the base 14 in thisposition. Surfaces of the post 20 abut against surfaces of the cover 22formed by the lip 38 and walls 46 of the opening 32. The posts 20 of thebase 14 and the slotted holes 67, 77 of the cover 22 thereby form alatching structure. The latching structure allows the posts 20 to beeasily inserted into the openings 32 in one position but inhibitsunintentional retraction of the posts 20 from the openings 32 in asecond position.

Additionally, the underside 30 of the post head 26 seats against thecover 22 with the periphery of the head 26 at the edge of the depression40, as shown. A slight deformation of the head 26 and/or edge of thedepression 40 creates increased interference between the cover 22 andthe post heads 26 which aids in maintaining the cover 22 in place,relative to the posts 20.

It will be understood that, in other arrangements, the openings caninstead be formed in the base, rather than the cover, and the postsformed on the cover. In such a case, each opening would comprise apartial central hole in the base, below which a hollow space is formedfor receiving the heads of downward extending posts of the cover. Thespace would also accommodate the lateral movement of the cover (andconsequent lateral movement of the posts) in order to provide engagementbetween the shaft of each post and a narrow slot extending from theopening. In this manner, the head of one of the posts would be capturedwithin the hollow space below each slot. The post could not be pulledout of the hollow space because the rear side of the post head wouldcontact the portions of the base which define the slot. Such a latchingmechanism is disclosed in copending application Ser. No. 08/587,092,entitled “Catheter Anchoring System”, filed on Jan. 15, 1996, in thename of Steven F. Bierman and assigned to the assignee hereof, whichstands allowed as of the filing date of this application and which ishereby incorporated by reference.

In initial application, the illustrated retainer 10, with the fitting 11and the catheter retained in it as described above, is secured to thepatient by way of the self-adhesive anchor pad 16. The health careprovider selects a skin site on which the retainer 10 will be attached.For use with CVCs and PICCs, the retainer 10 desirably is applied to theskin of the patient in the vicinity of the catheter insertion site. Thehealth care provider then cleanses and prepares the anticipated dressingsite according to well known methods, usually swabbing with alcohol andallowing the site to dry thoroughly. The health care provider peels awayhalf of the backing layer 17 from the adhesive surface of the anchor pad16, properly locates the pad 16 on the patient, and presses the exposedadhesive against the patient's skin to secure the anchor pad 16 to thepatient. The second half of the backing layer 17 is then removed, andthe second half of the anchor pad 17 adhered to the patient's skin. Theanchor pad 16 should be mounted on the patient so that catheter overliesthe retainer 10 along the retainer's longitudinal axis.

When removal of the catheter becomes necessary, the cover 22 simply isslid horizontally in the opposite direction, desirably with forcesufficient to compress cover material at the waists 37, so that theheads 26 of the posts 20 are once again aligned with the central holes34. The cover 22 can then be easily lifted transversely from the base14. With the retainer 10 thus unlatched, the fitting 11 can also beremoved. The catheter secured by the fitting 11 can then be changed orcleaned and replaced in the retainer 10, without requiring a newretainer.

It should be noted that a deliberate effort is generally required todisengage the post shafts 25 from the slots 36, due to the retentionmechanism formed by the narrow neck 37 and/or depression 40. Theretainer 10 thus releasably mounts a catheter (or other medical line)and can be reused without requiring reattachment to the patient, whileat the same time inhibiting accidental release of the catheter.

Significantly, the removed cover 22 remains leashed to the retainer base14, which remains attached to the patient. Thus, the health careprovider need not take care to place the cover 22 in a safe hygienicplace, nor keep track of its whereabouts. The cover 22 can simply hangfrom the base 14 by the leash 24, where it is easily found and relatchedto the base 14 when a new catheter is engaged. Furthermore, each timethe cover is relatched, the cover 22 is automatically correctlyoriented, such that the health care provider need not take care toensure that the depression 40 is facing the correct direction, nor toensure that the slots 36 are on the correct side.

Of course, if the medical treatment is completed and there is no need toreuse the retainer 10, the health care provider can release the coverfrom the base in the manner described above. The medical article thencan be lifted from the base. To remove the anchor pad 16, the healthcare provider lifts an edge of the pad 16 and gently strokes theundersurface with an alcohol swab while slowly but continuously liftingthe edge. The anchor pad 16 can be peeled from the patient's skin inthis manner. The health care provider then cleanses and prepares skinusing well known hospital or agency protocols.

A retainer 10 a in accordance with another embodiment of the inventionis illustrated in FIGS. 4A to 5, with FIG. 4A showing a completely openposition of the retainer 10 a and FIG. 5 showing the partially closedposition, similar to FIGS. 1-2 above. Though not illustrated, thisretainer 10 a also desirably includes a flexible anchor pad, asillustrated in FIG. 1, for adhesive attachment to the body of a patient.Only the cover 22 a of this embodiment differs from the above-describedembodiment. Accordingly, the above description applies equally to theembodiment of FIGS. 4-5, unless otherwise indicated. In addition, likereference numerals are used to indicate like features of the twoembodiments, with the letter “a” added as a suffix to refer to featuresof the present embodiment.

The cover 22 a of this retention mechanism 14 a includes a pair ofopenings 32 a. In contrast to the embodiment discussed above, eachopening 32 a comprises a single slot 80 extending from a longitudinalouter edge 82 of the cover 22 a to a terminus 84. The pair of slots 80can extend from either of the two outer edges 82, but both slots 80desirably extend from the same edge.

The slots 80 advantageously extend obliquely from the outer edge 82 ofthe cover 22 a to the slot terminus 84, such that one side of each slot80 defines an obtuse angle α (FIG. 4B) with the outer edge 82 from whichthe slot extends, as shown in FIG. 4B. The termini 84 of the slots 80desirably are centered on or close to a lateral line that bisects thecover 22 a into longitudinal halves. Thus, the length of each slot 80depends upon the obtuse angle a between the outer edge 82 and the slot80. The angle α should be small enough and the slot 80 short enough thatthe structural integrity of the cover 22 a is not compromised. Whileillustrated as parallel, the slots 80 can also be arranged at a slightangle to one another. The width of each slot 80 desirably is slightlylarger than the diameter of the post shaft 25 a, and smaller than thelargest dimension of the post head 26 a.

As best seen from the plan view of FIG. 4B, the opening 32 a desirablyincludes a retention mechanism, such as to inhibit retraction of thepost 20 a from the slot 80. As visible from the views of FIGS. 4B and 5,each slot 80 is partially defined at the terminus 84 by a lip 38 a ofcover material, forming a depression 40 a in the cover 22 a, similar tothe lip 38 and depression 40 shown in FIGS. 1-3. The depression 40 a issized slightly smaller than the lower surface 30 a of the post head 26a.

In the illustrated embodiment, the retention mechanism further comprisesone or more protuberances 86 extending at certain positions frominterior walls of the slot 80. As illustrated, the protuberances 86desirably are positioned within the slot 80 just outside the depression40 a. At the protuberances 86, the slot 36 a most desirably has aslightly smaller diameter than the shaft 25 a, while widening toslightly larger than the shaft 25 a at the lip 38 a. These protuberances86 define the waist 37 a of the opening 32 a for the present embodiment.

FIG. 5 illustrates the retainer 10 a in a partially closed position. Theflexible leash 24 a has been bent to swing the cover 22 acounterclockwise (in the view of FIG. 5), bringing the openings 32 a inproximity to the posts 20 a. The cover 22 a continues in a downward arcfrom the position of FIG. 5 and is shifted slightly out of alignmentwith the base 14 a until the edge openings of the openings 32 a at thelongitudinal edge 82 are adjacent to the section of the posts 20 abetween the head 26 a and the ring 28 a.

While not illustrated in FIGS. 4A to 5, a catheter fitting can first bemounted to the retainer 10 a prior to latching. For example, the fitting11 a illustrated in FIGS. 1-3 can be first secured to the retainer. Forsuch a case, the posts 20 a serve as a portion of an interactingstructure and the holes 67 a, 77 a of the fitting 11 a serve as anotherportion of the interacting structure. The interacting structure thusmounts the fitting to the retainer to inhibit at least one degree ofmovement of the fitting relative to the retainer. Alternatively, aportion of the interacting structure can directly mount a catheter,without the intermediate fitting.

The shaft 25 a of each post 20 a (between the head 26 a and the ring 28a) can be easily inserted into the edge opening of the openings 32 a atthe outer edge 82. The cover 22 a is then shifted obliquely such thatthe shafts 25 a slide along the slots 80. The shafts 25 a and/or theprotuberances 86 are compressed or the protuberances are deflected asthe shafts 25 a slide past the protuberances 86. After the shafts 25 ahave passed the protuberances 86, the shafts and/or the protuberancescan regain their original shape such that the shafts snap into theposition adjacent to the protuberances 86 and engage with the terminus84 of the slots 80. When the head 26 a is seated at the edge of thedepression 40 a, the surfaces of the cover 22 a formed by the lip 38 aand the protuberances 86 of the slot 80 abut against the shaft 25 a ofthe post 20 a. The cover 22 a is thus latched in a closed position.

In order to remove the cover 22 a from the base 14 a, the sliding motionof the cover 22 a over the posts 20 a is simply reversed until the postshafts 25 a exit the openings 32 a at the outer edge 82 of the cover 22a. Note that some deliberate force is generally required to overcome theretention mechanism. Namely, the cover 22 a is slightly depressed todisengage the underside of the head 26 a from the edge of the depression40 a, and the cover 22 a is slid with sufficient force to deflect orcompress the protuberances 86. Any fitting secured therein can then bedisengaged from the opened retainer 10 a.

Where the slots are arranged at a slight angle to one another, thefriction fit of the posts within the slots will improve, relative to anexactly parallel arrangement. It will be understood that, in otherarrangements, a similar slot can extend perpendicularly from thelongitudinal edge. Alternatively, slots of each opening can extend fromopposite longitudinal edges of the cover. In the latter arrangement, thecover would be aligned longitudinally between the posts and the covertwisted to a lateral alignment, such that the posts each engage theslots on each side. As will be understood by one of skill in this art,such slots would desirably extend along the circumference of a circlecentered between the termini.

In either of the above illustrated embodiments, or in invertedarrangements with the posts on the cover, the posts serve both as aninteracting structure (for mounting a medical line or fitting) and as apart of the latching structure (for latching the cover to the base). Itwill be understood, however, from the description of the following twoembodiments, that the posts can serve only as part of the latchingstructure, or only as part of the interacting structure. It will furtherbe understood by one of ordinary skill in this art that the posts can beabsent altogether in other arrangements.

FIGS. 6-9 illustrate a retainer 10 b in accordance with anotherembodiment of the present invention. The retainer 10 b is shown in anopen position in FIG. 6 and in a fully closed and latched position inFIG. 7. Other components of the anchoring system 8 b (e.g., anchor pad,catheter adapter) can be the same as described above with respect toFIGS. 1-3. Accordingly, the above description applies equally to theembodiment of FIGS. 6-9, unless otherwise indicated. In addition, likereference numerals are used to indicate like features among theembodiments, with the letter “b” added as a suffix to refer to featuresof the present embodiment.

The base 14 b includes a pair of posts 20 b; however, the base caninclude more or less posts depending upon the application of theanchoring system. Each post 20 b has a relatively smooth, continuoussurface up to a tip 90 which need not protrude radially from the post 20b, unlike the head 26, 26 a of the previously described embodiments. Thetip 90 of the post 20 b can be a flat surface or can taper into ahemispherical shape (as shown), a conical shape or other well knownshapes. In the illustrated embodiment, the posts 20 b each consist onlyof a simple shaft tapered hemispherically at the tip 90. The posts 20 botherwise desirably have the same diameter, spacing, and height of theposts 20, 20 a of the previous embodiments. The posts 20 b areillustrated as connected to a platform 21 b of the base 14 a, althoughit will be appreciated by those skilled in the art, in light of theabove disclosure, that the posts could be connected to the cover 22 b.

The flexible hinge 24 b of this embodiment comprises a relatively rigidsupport arm 92 that is integrally joined to the platform 21 b at a baseend 94. As shown in FIG. 6, the support arm 92 extends upwardly from thebase end 94 to join with the cover 22 b at a thin bridge 96 of covermaterial. The bridge 96 is formed along a common exterior surface 98(see FIG. 7) of the cover 22 b and the support arm 92. The bridge 96 isdefined along the apex of a notch 100 in the material that forms thecover 22 b and support arm 92. The notch 100 can be thought of as thestructure formed by a beveled edge sloping away from an interior surface102 of the cover 22 b, conjoined at the bridge 96 with a beveled edgesloping away from an inside surface 104 of the support arm 92. The hinge24 b flexibly connecting the base 14 b to the cover 22 b thus comprisesthe support arm 92, the bridge 96, and the surfaces forming the notch100. In other arrangements, however, the hinge of an embodimentresembling that of FIGS. 6-9 can comprise a structure similar to aconventional hinge pin-bracket arrangement.

Desirably, the support arm 92, which terminates at an upper end at thebridge 96, has the same height as the posts 20 b. It will be understood,however, that the support arm 92 can be higher than the posts 20 b inother arrangements.

The thickness of the bridge 96 depends upon the material chosen, and isthick enough to provide the desired strength to connect the support arm92 to the cover 22 b, but thin enough to provide flexibility for openingand closing the retainer 10 b. Desirably, the retainer 10 b isintegrally injection molded of a resilient polymer material, such aspolypropylene or polyethylene. For such materials, the bridge 96 has athickness between about 0.5 mm and 2.5 mm, and desirably about 1.5 mm.

The flexibility of the hinge 24 b also depends in part upon the angleformed by surfaces of the notch 100 when the retainer 10 b is in theopen position shown in FIG. 6. Desirably, the notch 100 defines an angleof at least about 90E, and particularly about 115E. Such an arrangementallows the cover 22 b to lie parallel to the platform 21 b when theretainer 10 b is in the closed position shown in FIG. 7. It will beunderstood, however, that in other arrangements the closed cover neednot lie parallel to the platform 14 b (and may take a curvilinear pathas described below).

As seen in FIG. 7A, the latching mechanism 110 b of the illustratedretainer 10 b comprising a fastening pin 112 and a latch having areceptacle 114. The receptacle 114 is configured to receive thefastening pin 112. As shown in FIGS. 6-9, the illustrated fastening pin112 is integrally connected to the cover 22 b and the receptacle 114 isintegrally connected to the base 14 b. It will be understood, however,that the pin can instead be positioned on the base, while the receptacleis positioned on the cover.

The fastening pin 112 includes a bar 116 extending from the cover 22 b(or the base 14 b, depending on the position of the element). At the enddistal from the connection to the cover 22 b, the bar 116 connects to anexpanded portion or barb 118 which tapers to a terminus 120 of the pin112. Like the post head 26, 26 a of the previous embodiments, the barb118 of the fastening pin 112 can be formed in any of a variety of shapessuch as an arrowhead (as shown), hemispherical, conical or flexible ribsextending outward from the bar 116. Desirably, the terminus 120 of thefastening pin 112 is relatively blunt and smooth to prevent it frompuncturing the gloves of a health care provider or catching on othermaterials. The barb 118 also desirably includes a sloping or curvedsurface 121 leading from the terminus 120 to the maximum diameter of thebarb 118. At least one shoulder is formed behind the barb 118. In theillustrated embodiment, shoulders are defined on either side of the bar116.

The receptacle 114 of the latch 110 b comprises a pair of opposing tangs122 that extend to a stem 124 connected to the base 14 b (or cover 22 b,depending on the position of this element of the latch). Each tang 122extends outwardly to a lug 126 that can be depressed by finger pressure.Desirably, each tang 122 includes an inner beveled surface 127. Thesebeveled surfaces define an aperture 128 therebetween which tapers from awider dimension at the top to a narrower dimension at the bottom, whereit communicates with a slot 130 located between the opposing stems 124.Each tang defines a downward facing shoulder that cooperates with one ofthe shoulders of the fastening pin barb 118, as described below.

In operation, a fitting, such as the fitting 11 of FIGS. 1-3, can befirst engaged with the posts 20 b while the retainer 10 b is open (seeFIG. 6). Accordingly, the posts 20 b of the illustrated embodiment forma portion of the interacting structure for inhibiting movement of amedical line fitting relative to the retainer 10 b.

The cover 22 b can then swing to a closed position as shown in FIG. 7.The relatively thin strip of material forming the bridge 96 allows thehinge 24 b to bend when finger pressure is exerted on the cover 22 b tolower it. The angle of the notch 100 further allows the cover 22 to beclosed without compressing material between the interior surface 102 ofthe cover and the inner surface of the support arm 92. While the rigidsupport arm 92 and the thin bridge 96 permit only rotational and notlateral movement of the cover 22 b relative to the base 14 b, suchlateral movement is not necessary for the illustrated latchingmechanism.

The fastening pin 112 can be inserted into the receptacle 114 bypositioning the pin 112 into the aperture 128 and pressing on the cover22 b. The sloped surfaces 121 of the fastening pin 112 slide over thebeveled inner surfaces 127 of the tangs 122. The interaction of thesesloped and beveled surfaces tends to distend the tangs 122 slightly,thereby allowing the barb 118 to enter the slot 130. The tangs 122 thensnap back into their original position and engage with the barb 118 ofthe pin 112 with the corresponding shoulders abutting, therebyreleasably securing the cover 22 b to the base 14 b. FIG. 8 illustratesthe closed latch 110 b.

When the latch 110 b is closed, as shown in FIG. 7, the inner surface102 of the cover 22 b sits atop the tip 90 of the posts 20 b, since theposts of the illustrated retainer 10 b have the same height as thesupport arm 92. It will be understood that, in arrangements where theposts are attached to the cover, the tips would abut the base when thecover is in the closed position and latched. Where such contact takesplace, a fitting secured between the cover 22 b and the base 14 b couldnot slip off the posts 20 b when the retainer 10 b is closed andlatched. Furthermore, the posts 20 b provide added support for the cover22 b in the closed position to prevent over-extension of the hinge 24 b.

To release the cover 22 b from the base 14 b, the health care providercan press down on the lugs 126, thereby gaining access to the fittingand/or catheter secured therein. When a lug 126 is depressed, theattached stem 124 bends outward slightly, causing the tang 122 to movedoutwardly and the slot 128 to expand, as shown in FIG. 9. To providefriction between the health care provider's finger and the top of thelug 124, ridges or other types of roughened surface can be included.

When only a single lug 124 is depressed, however, the attached tang 122is elevated until it contacts the surface of the element (e.g., thecover) to which the fastening pin 112 is connected. This degree ofelevation of a single tang 122 does not expand the aperture 128sufficiently to release the barb 118 of the fastening pin 112. Incontrast, when both lugs 124 are depressed (not shown), the aperture 128is sufficiently widened to allow the fastening pin 112 to be readilyextracted from the receptacle 114. This design prevents inadvertentrelease of the fastening pin 112 (e.g., when a lug is bumped), butpermits easy opening of the retainer 10 b when a health care providerseeks to move the catheter or other fitting held within the retainer 10b.

FIGS. 10-12 illustrate an anchoring system 8 c in accordance withanother embodiment of the present invention. Like the anchoring systemsdescribed above, the illustrated embodiment includes a retainer 10 c, afitting or adaptor 11 c and an anchor pad 16 c. The anchor pad 16 cdesirably is similar to the anchor pad 16 described with respect to FIG.1. The retainer 10 c and the fitting 11 c differ somewhat from theabove-described embodiments, though certain features are the same.Accordingly, the above description applies equally to the embodiment ofFIGS. 10-12, unless otherwise indicated. In addition, like referencenumerals are used for like features among the embodiments, with theletter “c” added as a suffix to refer to features of the presentembodiment.

The illustrated posts 20 c do not include a locator ring of materialbelow the head 26 c. The illustrated base 14 c, including dimensions ofthe posts 20 c, is otherwise identical to the base 14 described withrespect to FIGS. 1-3. Unlike the openings 32, 32 a of the previousembodiments, the illustrated opening 32 c is shown without a lip ordepression in the slot 36 c. It will be understood, however, that theslot can also include a depression over which the post head would seatwithout departing from the principles of the present embodiment.

Like the previous embodiments, the present embodiment includesinterengaging structure to mount the medical line to the retainer 10 c.In the illustrated embodiment, the interacting structure comprises achannel defined by a mounting structure 140. The channel is sized andshaped to mount a medical line, such as a catheter, either directly orindirectly by way of a fitting. Desirably, the channel defined by themounting structure 140 is configured to mate with and mount the adaptor11 c which, in turn, engages with the medical line. In the illustratedembodiment, the mounting structure 140 is integrally formed with thecover 22 c, such as by injection molding. It will be understood,however, that the mounting structure 140 can equally well be formed aspart of the base 14 c without materially affecting the function of theretainer 10 c.

The illustrated mounting structure 140 comprises two substantiallyrectangular box-like extensions 141 that extends from the cover 22 cbetween the two openings 32 c. The extensions 141 are spaced by adistance sufficient to receive the adaptor 11 c and include inner faces142 configured to mate with surfaces of the adaptor 11 c. The innerfaces 142 are more particularly shaped to inhibit at least one degree offreedom, desirably to inhibit longitudinal movement of the adaptor 11 cwhen the adaptor is mounted within the channel (see FIG. 11). Theillustrated inner faces 142 are convex in shape. The channel definedbetween the extensions 141, thus, has a minimal width at a central pointand widens toward either longitudinal end. In other arrangements, theskilled artisan will recognize that a maximum channel width at a centralpoint will inhibit longitudinal movement of a different fitting. Where,as illustrated, the mounting structure 140 is integral with the cover 22c, the extensions 141 desirably are spaced closely enough to provide asnug or slight interference fit for the adaptor 11 c within the channel.

The mounting structure 140 (and the channel defined by it) has a heightless than or equal to the height of the post shafts 25 c of the base 14c. In the illustrated embodiment, the structure 140 is equal to theheight of the shafts 25 c, less the thickness of the cover 22 c. Anouter surface 144 (FIG. 10) of each of the illustrated extensions 141 isaccordingly configured to mate with the platform 21 c of the base 14 c,and is flat in this case.

The cover 22 c is illustrated with a slight hourglass shape, such as toprovide a slight indentation 146 along an edge 148 of the cover 22 c.Desirably, the indentation 146 comprises transverse ridges 150. Thisshape facilitates an interengagement between the fitting 11 c and themounting structure 140 to inhibit movement of the adaptor 11 c at leastin the longitudinal direction, as described below.

The fitting 11 c of the present embodiment is an in-line adaptor 11 c.This adaptor 11 c comprises an elongate structure defining a fluidpathway, and means for connecting the adaptor to lines at either end.The illustrated adaptor 11 c comprises a medical connector such as thosecommonly used to connect a supply line to a catheter.

Desirably, the adaptor 11 c is of a type similar to that disclosed withrespect to FIGS. 11 and 12 of U.S. Pat. No. 5,306,243 (“the '243patent”), the disclosure of which is hereby incorporated herein byreference. The adaptor 11 c includes a male connector 160 for connectionto a catheter and a female connector 162 for connection to a medicalsupply or delivery tube (e.g., leading to an IV drip or a suction pump).The illustrated male connector 160 includes a Luer-type fitting 164 withinternal threads and a tapered nose extending outwardly, with aninternal passageway for fluid communication with a catheter.

The female connector 162 comprises external threads 166 and a membrane168 for sealing the internal passageway. The membrane 168 can comprise aclosed septum, through which a sharp needle is inserted to providecommunication between the supply or delivery tube and the internalpassageway. The membrane 168 can also comprise a pre-slit membrane,through which a blunt needle provides communication between the supplyor delivery tube and the internal passageway. Desirably, however, thefemale connector 162 of the adaptor 11 c comprises an internal needleintegral with the internal passageway, as disclosed in the '243 patent.The membrane 168 comprises a resilient, self-sealing material which isoutwardly biased.

An adaptor body 170, between the male connector 160 and the femaleconnector 162, comprises mounting surfaces 172 which form a portion ofthe interacting structure of the anchoring system 8 c. The illustratedmounting surfaces 172 comprise opposed concave surfaces, desirablyincluding ridges (not shown) to facilitate finger gripping duringconnection of the adaptor 11 c to catheters or other medical tubes. Inthis manner, the adaptor body 170 has a minimal width at a central pointand widens toward both the female connector 162 and the male connector160. In particular, the widest points of the illustrated adaptor 11 care wider than the most narrow portion of the channel between theextensions 141 of the retainer 10 c.

The mounting surfaces 172 are joined by a top surface 174 and a bottomsurface (not shown). The top and bottom surfaces desirably are flat tomate with the illustrated cover 22 c and platform 21 c of the retainer10 c, such that these surfaces also form a portion of the interactingstructure.

In operation, the adaptor 11 c can first be connected to medical tubes.For example, a catheter can be fitted with a female connector withexternal threading, similar to the female connector 162 of the adaptor11 c. Such a connector can be quickly and easily threaded into the maleconnector 160 of the adaptor without any external needles, thus reducingthe likelihood of needle sticks to the health care provider. While thefemale connector is threaded into the Luer-type fitting of the maleconnector 160, the nose of the male connector 160 forces the membrane168 backwards over the internal needle, thus providing fluidcommunication between the catheter and the internal passage of theadaptor 11 c. Similarly, a medical delivery/supply line can be fittedwith a male connector similar to the male connector 160 of the adaptor11 c. Such a connector would then connect with the female connector 162of the adaptor 11 c, thereby completing fluid communication through theadaptor 11 c between the delivery/supply line and the catheter.

The adaptor 11 c then mounts within the channel defined by the mountingstructure 140 of the retainer 10 c. In the illustrated embodiment,wherein the mounting structure 140 is formed integrally with the cover22 c, the inner faces 142 of the extensions 141 desirably snugly receiveand grip the mounting surfaces 172 of the adaptor 11 c.

It will be understood by one of skill in the art, however, that the fitneed not be tight enough to inhibit transverse movement of the fittingor adaptor, particularly where the mounting structure is integral to thebase, rather than integral to the cover. Desirably, however, theinteraction between the mounting structure inner faces 142 and theadaptor mounting surfaces 172 is such as to inhibit significantlongitudinal movement (e.g., more than 1-2 mm) of the adaptor 11 c. Inthe illustrated embodiment, the minimal width of the channel is morenarrow than the widest portions on either end of the adaptor body 170.

With the adaptor 11 c thus mounted to the retainer 10 c, the retainer 10c is then be closed and latched, as described with respect to theprevious embodiments. Where, as illustrated, the mounting structure 140is located on the cover 22 c, if the mounting structure 140 is notconfigured for firm engagement, the health care provider can hold theadaptor 11 c within the channel until the retainer 10 c is latched. FIG.11 illustrates the retainer 10 c in a partially closed condition.

FIG. 12 illustrates the retainer 10 c latched closed with the adaptor 11c retained therein. As will be understood by one of skill in the art,the cover 22 c and the base 14 c interposed the adaptor 11 c betweenthem, preventing transverse movement of the adaptor 11 c relative to theretainer 14 c. The channel defined by the mounting structure 140inhibits lateral or longitudinal movement of the adaptor 11 c relativeto the retainer 14 c by the cooperating shape of the channel and theadaptor 11 c (which form the interengaging structure in thisembodiment). Accordingly, the adaptor 11 c is sufficiently restrained tosecure a catheter extending therefrom to the patient. If the catheterhad not been secured to the adaptor prior to engagement of the adaptorto the retainer, the catheter can be secured after engagement.

The skilled artisan will appreciate that the retainers disclosed hereindemonstrate versatility in securing a great variety of medical articlesto a patient. Retainers similar to those of FIGS. 1-9 can be utilized tosecure any device which is provided with holes spaced apart to engagewith the posts. The cover is secured to the base to interpose the devicebetween them. Many medical devices are already provided with sutureholes which can be fitted over the retainer posts disclosed herein.Other devices can be modified to include such holes. Other arrangementsto secure a medical article to the posts, either between the posts oradjacent to a single post, will be readily apparent to those skilled inthe art in light of the disclosure herein.

Medical devices can be also be provided with surfaces similar to themounting surfaces 172 of the illustrated adaptor 11 c, for mountingwithin the integral channel of the retainer 10 c illustrated in FIGS.10-12. Y-joint adapters, for example, can be adapted to mount within thechannel of the retainer 10 c shown in FIGS. 10-12.

Alternatively, one of skill in the art will readily appreciate that thedisclosed retainers can be modified, without departing from the spiritof the invention, to mount and retain existing medical devices. Forexample, the integral mounting structure illustrated in FIGS. 10-12 canbe adapted to clamp existing Y-joint adapters, or to directly mount acatheter or other medical line without the need for an intermediatefitting. In addition, the channel can have a semi-tubular shape andinclude at least one lateral slot that receives a radially extendingmember of the adaptor (e.g., an annular collar). Desirably, any suchmodified mounting structure would inhibit longitudinal and lateralmovement of the device or medical line. Transverse movement is inhibitedby closure of the retainer with the device or line sandwiched betweenthe base and the cover.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. For example, theintegral mounting structure 140 of FIGS. 10-12 can be adapted formounting an adaptor in a retainer having the latch 70 of FIGS. 6-9, thusrequiring no posts. Similarly, the various posts, slotted holes, hinges,anchor pads and fittings disclosed herein, as well as other knownequivalents for each such feature, can be mixed and matched by one ofordinary skill in this art to construct anchoring systems in accordancewith principles of the present invention.

Although not illustrated, each of the illustrated retainers can beadapted for use in an anchoring system which includes a safety loop. Ananchor pad larger than the pad 16 illustrated in FIG. 1 can mount both aretainer, in accordance with one of the preferred embodiments, and aseparate tube clip. The medical line mounted by the retainer can also besecured less tightly to the tube clip, with an adequate amount of slackin the line between the retainer and the clip. The clip and theresultant slack are desirably located between the retainer and thecatheter insertion site, for example.

If movement by the patient causes a sudden pull upon catheter, thecatheter slips within the tube clip and the slack length or “safetyloop” of the tube is pulled through the clip. Friction between the clipand the sliding tube absorbs some of the force and some of the forcecauses a slight pull on the adhesive pad, functioning as a warning tothe patient to cease the undesirable movement.

Similarly, the retainer itself can be arranged to only slightly inhibitlongitudinal movement of a catheter, such as to allow some amount ofslip in response to large forces. For example, the fitting of FIGS. 1-3can comprise a soft wing clamp without the box clamp. In any of thesearrangements, a jerk upon the medical line can be largely absorbed byallowing some slip, without either disconnecting the line from thefitting or painfully pulling the anchor pad from the patient's skin.

Using a retainer in accordance with the above disclosure, no painful,invasive or time-consuming sutures or other extensive proceduresinvolving medical sharps (e.g., suture needles) are necessary to anchoran elongate medical article to a patient's skin. In addition, theflexible anchor pad absorbs much of the force incurred in theinstallation or removal of the retainer and the medical device, therebyproviding greater comfort for the patient.

As common to each of the above-described retainers and anchoringsystems, the present invention provides a sterile, tight-gripping,needle-free way to anchor medical articles to a patient. The retainersthus eliminate accidental needle sticks, suture wound site infectionsand scarring because sutures are not required. In addition, theretainers can be used with any of a wide variety of catheters, tubes,wires, and other medical articles to provide universal securement usingone style of retainer. Also, patient comfort is enhanced and applicationtime is decreased with the use of the present retainer.

The releasable engagement of the cover and the base allow the sameretainer to be used more than once on the same patient at theapplication location. That is, a first medical device can be mounted inthe retainer. When the function of the first medical device isaccomplished, the retainer can be unlatched, the first device removed,and a second medical device can be retained in the same retainer.Furthermore, the leash or hinge connecting the cover to the base ensuresthat the cover will not be lost or misplaced during a catheter change.The health care provider wastes no time in searching for a cover, nor inorienting the cover prior to latching.

Although this invention has been described in terms of certain preferredembodiments and suggested possible modifications thereto, otherembodiments and modifications apparent to those of ordinary skill in theart are also within the scope of this invention. Accordingly, the scopeof the invention is intended to be defined only by the claims whichfollow.

1. An anchoring system for securing a medical article having anirregularly shaped portion to the body of a patient, comprising: ananchor pad having an upper surface and a lower surface; and a retainercomprising, a channel having an irregular shape along its length andbeing located above the anchor pad, the irregular shape of the channelgenerally corresponding to the irregularly shaped portion of the medicalarticle to be secured, and a cover being movable relative to theretainer so as to move between an open position and a closed position,the cover lying above at least part of the channel when in the closedposition so as to inhibit the irregularly shaped portion of the medicalarticle moving relative to the retainer.
 2. The anchoring system ofclaim 1, wherein the retainer comprises a base, the cover being arrangedrelative to the base so as to cover at least a portion of the base whenin the closed position.
 3. The anchoring system of claim 2, wherein thecover is permanently coupled to the base.
 4. The anchoring system ofclaim 2, wherein the base defines a receiving space on the retainer, andwherein the cover is arranged on the base so as to cover at least aportion of the receiving space when in the closed position.
 5. Theanchoring system of claim 1, wherein the cover lies generally to atleast one side of the channel in the open position to thereby expose thechannel.
 6. The anchoring system of claim 1, wherein the cover has awidth in a longitudinal direction that is narrower than a width of thecover in a lateral direction.
 7. The anchoring system of claim 1,wherein the cover has a width sufficient to inhibit movement of asection of the secured medical article in at least one directionrelative to the channel.
 8. The anchoring system of claim 1, wherein thechannel comprises a bottom side, the cover being arranged relative tothe bottom side so as to cover at least a portion of the bottom sidewhen in the closed position.
 9. The anchoring system of claim 1, whereinthe channel is formed as part of the cover.
 10. The anchoring system ofclaim 1, wherein at least a portion of the lower surface has an adhesivesurface to attach the anchor pad to the body of the patient.
 11. Theanchoring system of claim 1, wherein at least a portion of the channeltapers from a wider shape to a narrower shape.
 12. The anchoring systemof claim 11, wherein a first portion of the channel has a lateral widththat is greater than a lateral width of a second portion of theirregularly shaped channel.
 13. The anchoring system of claim 2, whereinthe channel is at least partially defined by a first extensionpositioned between the base and the cover when the cover is in theclosed position.
 14. The anchor system of claim 13, wherein the firstextension extends from the cover.
 15. The anchoring system of claim 13,wherein the first extension extends from the base.
 16. The anchoringsystem of claim 13, wherein the channel further comprises a secondextension positioned between the base and the cover and adjacent tofirst extension when with the cover is in the closed position.
 17. Theanchoring system of claim 16, wherein the cover extends over at leastpart of both first and second extensions when in the closed position.18. The anchoring system of claim 16, wherein the cover has a length ina lateral direction sufficient to extend between the first and secondextensions.
 19. The anchoring system of claim 16, wherein the firstextension comprises a first inner face and the second extensioncomprises a second inner face, wherein the first inner face is arrangedto oppose the second inner face.
 20. The anchoring system of claim 19,wherein the first inner face and the second inner face are convex. 21.The anchoring system of claim 19, wherein the first inner face is amirror image of the second inner face.
 22. The anchoring system of claim2, wherein the retainer further comprises a post arranged between thebase and the cover when the cover is in the closed position, and whereinthe post extends generally normal to a longitudinal axis of the cover.23. The anchoring system of claim 22, wherein the cover includes areceptacle for receiving at least a portion of the post when the coveris in the closed position.
 24. The anchoring system of claim 23, furthercomprising a latching mechanism operable between the base and the coverto releasably secure the cover to the base when in the closed position.25. The anchoring system of claim 2 additionally comprising a flexiblehinge that couples the base to the cover.
 26. The anchoring system ofclaim 25, wherein the flexible hinge comprises an elongated leashextending between and coupled to the cover and the base.
 27. Theanchoring system of claim 25, wherein the flexible hinge comprises arigid support arm fixed to the base and a flexible bridge extendingbetween the support arm and the cover.
 28. The anchoring system of claim25, wherein the flexible hinge is integrally formed with the base andcover and which adopts a flat shape when the cover is in the openposition and a curved shape when the cover is in the closed position.29. The anchoring system of claim 2 wherein the base and cover of theretainer are formed as a unitary piece.
 30. A method of securing atleast a portion of a medical article to the body of a patient, themethod comprising: providing an anchoring device having an anchor padand a retainer, the retainer attached to an upper surface of the anchorand comprising an irregularly shaped channel and a cover, theirregularly shaped channel being located above the anchor pad and havinga shape which generally corresponds to the shape of the portion of themedical article to be secured, and the cover being movably connected soas to move between an open position and a closed position, the coverlying above at least part of the irregularly shaped channel when in theclosed position so as to inhibit the irregularly shaped portion of themedical article from moving in a transverse direction relative to thechannel; positioning the cover into the open position; inserting atleast a portion of the medical article into the channel, wherein a firstlongitudinal location along the channel has a lateral width whichexceeds a second longitudinal location along the channel; positioningthe cover into the closed position so as to grip the secured portion ofthe medical article in a non-occlusive manner; and securing theanchoring device to the patient.
 31. The method of claim 30, wherein thecover when in the closed position and the channel cooperate to inhibitlongitudinal movement of the secured portion of the medical articlerelative to the retainer.
 32. The method of claim 30, wherein thechannel comprises means for inhibiting the secured portion of themedical article from moving relative to the retainer.
 33. The method ofclaim 30, wherein the anchor pad comprises an upper surface and a lowersurface, at least a portion of the lower surface having an adhesivesurface.
 34. The method of claim 33, wherein securing the anchoringdevice to the patient comprises exposing at least a portion of theadhesive surface of the lower surface of the anchor pad and attachingthe adhesive surface to the patient.
 35. An anchoring system forsecuring an elongated medical article to a patient, comprising: ananchor pad having an upper surface and a lower surface; and a retainermounted on the upper surface of the anchor pad and being capable ofreceiving a portion of the medical article, the retainer including, achannel having a bottom surface and first and second surfaces forming anirregular shape that generally corresponds to the shape of the elongatedmedical article to be secured wherein the first surface is arrangedrelative to the second surface so that at least a portion of the medicalarticle fits there between, and a cover having a first end and a secondend, the first end of the cover being coupled to the retainer, and thesecond end of the cover being movable between a closed position, inwhich the second end of the cover lies generally above the channel, andan open position, in which the second end of the cover is spaced apartfrom the channel so as to allow ingress of the medical article into thechannel.
 36. The anchoring system of claim 35, wherein the first surfaceis arranged relative to the second surface so that a first distancebetween the first and second surfaces at a first longitudinal locationdiffers from a second distance between the first and second surfaces ata second longitudinal location.
 37. The anchoring system of claim 35,wherein the cover has a dome arranged between the first and second endsof the cover, the dome sized and configured to accommodate a portion ofthe medical article.
 38. The anchoring system of claim 35, wherein apost is arranged between the first and second ends of the cover when thecover is in the closed position, and wherein the post extends generallynormal to a longitudinal axis of the over.
 39. The anchoring system ofclaim 38, wherein the cover includes a receptacle for receiving at leasta portion of the post when the cover is in the closed position.
 40. Theanchoring system of claim 35, wherein the retainer comprises a base, thecover being arranged relative to the base so as to cover at least aportion of the base when in the closed position.
 41. The anchoringsystem of claim 40 additionally comprising a flexible hinge that couplesthe base to the cover.
 42. The anchoring system of claim 41, wherein theflexible hinge comprises an elongated leash extending between andcoupled to the cover and the base.
 43. The anchoring system of claim 41,wherein the flexible hinge comprises a rigid support arm fixed to thebase and a flexible bridge extending between the support arm and thecover.
 44. The anchoring system of claim 41, wherein the flexible hingeis integrally formed with the base and cover and which adopts a flatshape when the cover is in the open position and a curved shape when thecover is in the closed position.
 45. An anchoring system comprising: amedical article having an elongated body at least of portion of whichbeing irregularly shaped such that the width of the medical articlevaries along its length; and a retainer having a base having a bottomsurface, a channel located above the bottom surface and having a varyingwidth that is configured to generally match at least part of theirregularly shaped portion of the elongated body, and a cover locatedover at least a portion of the channel and movable between an openposition and a closed position, the cover cooperating with the channelto inhibit at least part of the irregularly shaped portion of theelongated body from moving relative to the retainer.
 46. The anchoringsystem of claim 45, wherein at least a portion of the channel tapersfrom a wider shape to a narrower shape.
 47. The anchoring system ofclaim 45, wherein a first portion of the channel has a width that isgreater than a second portion of the channel.
 48. The anchoring systemof claim 45, wherein at least a portion of the channel has an hourglassshape.
 49. The anchoring system of claim 45, wherein the retainerfurther comprises a generally transverse post which engages with thecover to inhibit movement of the cover relative to the channel.
 50. Theanchoring system of claim 49, wherein the post is located adjacent tothe channel.
 51. The anchoring system of claim 45, wherein the retainercomprises a base, the cover being arranged relative to the base so as tocover at least a portion of the base when in the closed position. 52.The anchoring system of claim 51 additionally comprising a flexiblehinge that couples the base to the cover.
 53. The anchoring system ofclaim 51 wherein the flexible hinge comprises an elongated leashextending between and coupled to the cover and the base.
 54. Theanchoring system of claim 51, wherein the flexible hinge comprises arigid support arm fixed to the base and a flexible bridge extendingbetween the support arm and the cover.
 55. The anchoring system of claim51, wherein the flexible hinge is integrally formed with the base andcover and which adopts a flat shape when the cover is in the openposition and a curved shape when the cover is in the closed position.